Solar Wave 16
The device is an over-the-counter tanning device emitting ultraviolet light in the UVB and UVA region of the spectrum intended for the tanning the human skin of an adult person.
1manufacturer
1catalogue number
Who Else Makes It
Registered in Shanghai. One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Global Fabtech Wheel Chair (Shanghai) Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 15 |
Record
| Listed by | Sunshine USA, LLC, United States |
|---|---|
| FDA product code | LEJ |
| Device type | Booth, Sun Tan |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4635 |
| Establishment | Manufacturer |
| 510(k) | K152423 |
| Record published | 2025-06-25 |
| Record revised | 2025-08-15 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SW16 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Genesis | Light Sources, Inc. | 65 |
| Booth, Sun Tan | Unilam Co., Ltd. | 64 |
| Renuvatan | Light Sources, Inc. | 60 |
| Original Hanau | G.L.E. Gesellschaft für lichttechnische Erzeugnisse mbH | 43 |
| Rave | Light Sources, Inc. | 41 |
| Brilliance | Light Sources, Inc. | 32 |
| Supra | Blv Licht-Und Vakuumtechnik GmbH | 30 |
| pureSunlight | Narva Lichtquellen GmbH + Co. KG | 22 |
| Signature Series | Light Sources, Inc. | 21 |
| Tanses T-32 Series | Tanses Technologies, Inc. | 20 |
| Perfect Bronze | Narva Lichtquellen GmbH + Co. KG | 20 |
| ProSun | Prosun International, LLC | 19 |
Showing 12 of 659. All products under Booth, Sun Tan
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.